510(k) K160461 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Arthrex iBalance BiCompartmental Arthroplasty System
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Apr 12, 2016 |
| Received | Feb 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160461
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.